Paula Munderi

Department of Essential Drugs and Medicines Policy

World Health Organization

Access to essential medicines for HIV/AIDS - update on WHO activities within UN framework

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Aims

enhance access to affordable HIV/AIDS medicines of assured quality

promote rational use of these drugs by professionals and consumers

provide technical support to the most affected countries towards integration of HIV/AIDS medicines into national essential drugs programmes

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1. Rational selection and use

Recent developments: WHO guidelines for a public health approach to on

scaling up antiretroviral therapy in resource limited

settings : http://www.who.int/HIV_AIDS

standardized and simplified regimens simplified patient monitoring

12 ARVs on WHO Model EML & WMF

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2. Affordable prices for governments, healthcare providers and consumers - strategies:

National policy• exemption from taxes, import duties• price regulation (producer prices, distribution margins)• WTO/TRIPs provisions

Market dynamics• generic competition

Procurement management• price information • price negotiation• group purchasing (public, NGO - national, regional)

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MSH-WHO essential drugs price indicator

Drugs and diagnostics for HIV/AIDS

Pharmaceutical starting materials

Antiretroviral drugs in the Americas

AFRO Essential Drugs

Indicative price information promotestransparency and competition

Affordable prices

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Annual cost per person for triple therapy (US $)

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

1991 1993 1995 1997 1999 2001 2003

UN Drug Access Initiative

Generic competition in Brazil

5-company offer

Generic company offer

Advocacy, corporate responsiveness, & market forces have reduced antiretrovial prices 95% in 2 years

UNDCP

UNDP

UNESCO

UNFPA

WIPO

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WHO policy and technical support on TRIPS to over 60 countries - health, trade and patent officials

Meeting on the impact of globalization (Jakarta, May 2000) (9)

Briefing on TRIPS (SADC) South Africa, June 2000) (7)

Workshop on TRIPS (Harare, August 2001) (4)

Intercountry meeting on the TRIPS Agreement (Warsaw, September 2001) (22)

Country support (9)

Participants in both, South Africa and Harare meetings (11)

Meeting on TRIPS in OAPI countries (Yaoundé, May 2002) (15)

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3. Sustainable financing

In over 38 countries public drug expenditures are<US$2 per capita - inadequate by most estimates

Key actions: Increase public funding for cost-effective drugs Expand drug benefits in health insurance Seek external funding for the poorest populations

(e.g. Global Fund)

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Pilot Procurement, Quality and Sourcing Project

Objective: Establish a Model Quality Assurance System for

Procurement of Pharmaceuticals Pre-qualification of suppliers of HIV/AIDS-related

pharmaceutical products Quality standards of newer HIV medicines Improved capacity of national regulatory bodies

Partners: UNAIDS, UNFPA, UNICEF, WHO, World Bank

Reliable systems

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4. Summary

UN framework for access includes rational selection, affordable prices, sustainable financing and reliable systems

UN, WHO and partners are active in all aspects of access Key tools available to governments and NGOs:

Treatment guidelines and essential medicines list Price information; pre-qualified suppliers and products Guidance on use of TRIPS safeguards Policy and training tools in supply management

(pricing, donations, procurement and supply management)

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what remains to be done

Adaptation of National Standard Treatment Guidelines

Adaptation of National Essential Medicines Lists

Training in Rational Use for Health Workers & Consumers

Updated review of Global Patent Status of HIV medicines

Specific guidance and country support on patents, IPR and

procurement of limited-source HIV medicines

More in area of financing options

Technical assistance for in-country supply systems

Systems of Drug Safety Monitoring